NCT02131636

Brief Summary

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 10, 2016

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

May 5, 2014

Results QC Date

December 29, 2015

Last Update Submit

November 15, 2019

Conditions

ErythemaRosacea

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales

    The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.

    Baseline, Day 29 (Hours 3, 6, 9, and 12)

Secondary Outcomes (5)

  • Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale

    Baseline, Day 29 (Hours 3, 6, 9, and 12)

  • Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)

    Baseline, Day 29 (Hours 3, 6, 9, and 12)

  • Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9

    Day 29 (Hours 3, 6, 9, and 12)

  • Change From Baseline on the SA-RFR Questionnaire Item #4

    Baseline, Day 29 (Hours 3, 6, 9, and 12)

  • Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale

    Baseline, Day 1 (Hour 1)

Study Arms (2)

AGN-199201

EXPERIMENTAL

AGN-199201 applied to the face once daily for 29 days.

Drug: AGN-199201

Vehicle

PLACEBO COMPARATOR

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Drug: Vehicle to AGN-199201

Interventions

AGN-199201DRUG

AGN-199201 applied to the face once daily for 29 days.

AGN-199201
Vehicle to AGN-199201DRUG

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe persistent facial erythema associated with rosacea.

You may not qualify if:

  • Greater than 3 inflammatory lesions on the face
  • Current treatment with monoamine oxidase (MAO) inhibitors
  • Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lynchburg, Virginia, United States

Location

MeSH Terms

Conditions

ErythemaRosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 6, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

November 18, 2019

Results First Posted

March 10, 2016

Record last verified: 2019-11

Locations

US(1)